Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Exercise Tolerance
研究概览
简要总结
The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, placebo controlled trial.
详细描述
Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current symptoms. At baseline a 6 minute walk test and quality of life questionnaire will be administered. Medical records will be reviewed and results of recent testing will be recorded. Qualifying participants will be randomized to receive 90 days of either placebo or sildenafil 20 mg three times a day. Randomized patients will be followed for safety and efficacy by phone and as otherwise clinically indicated.
At the end of the 90 day treatment period, patients will be evaluated via 6 minute walk, quality of life questionnaire, and other diagnostic tests as clinically indicated. Primary outcome will be change in the 6 minute walk distance. Secondary outcomes will be based on clinically available results such as change in heart pressures measured by right heart catheterization and echocardiogram.
At the end of the treatment period, providers and patients will be unblinded in order to optimize further treatment.
To achieve statistical significance, 64 patients will be enrolled and randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated
- •indication for right heart catheterization
- •pulmonary artery mean pressure >25 mmHg
- •pulmonary capillary wedge pressure > 15 mmHg
- •pulmonary vascular resistance > 3 Wood units
排除标准
- •hypersensitivity, allergy, or intolerable side effect to sildenafil
- •history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt
- •co-morbidities, limited exercise intolerance:
- •morbid obesity (BMI >40)
- •COPD with oxygen dependence
- •severe peripheral vascular disease with intermittent claudication
- •status post amputation of lower extremity at any level
- •severe degenerative joint disease preventing normal walking
研究组 & 干预措施
Placebo
Placebo three times per day, orally
干预措施: Placebo (Drug)
Sildenafil
Sildenafil 20 mg three times per day, orally
干预措施: Sildenafil (Drug)
结局指标
主要结局
Change in Exercise Tolerance
时间窗: Baseline and 90 days
In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment.
次要结局
未报告次要终点
研究者
Maya Guglin
Professor, Clinical Faculty
University of Kentucky